FDA approval

  •   Emma Shtivelman, PhD

    Excerpt from OncLive:

    “The FDA has approved enzalutamide (Xtandi) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the codevelopers of the antiandrogen agent.

    “The approval is based on the phase III PROSPER trial, in which the combination of enzalutamide (Xtandi) and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71% compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with enzalutamide plus ADT versus 14.7 months with ADT alone (HR, 0.29; 95% CI, 0.24-0.35; P <.0001).”

    Go to full article published by OncLive on July 13, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

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    Proposed FDA “Conditional Approval”- More Details

    With: Marty Tenenbaum, PhDAl Musella, DPM

    A Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY, and Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA Originally published May 10, 2017 Q: Your April 5, 2017 blog post that proposed a new “Conditional” category for FDA drug approval elicited a number of positive and negative responses. Please explain the proposal in more detail… Read more »

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    Conditional Approval: Right Solution for the Wrong Problem

    With: Shannon Brownlee, MS

    A Q&A with Shannon Brownlee, MS, Senior Vice President of the Lown Institute, a think tank in Boston. She is also co-founder of the Right Care Alliance, a social movement for transforming health care. Originally published April 26, 2017 Q: Musella and Tenenbaum recently proposed a new way, called conditional approval, for the American FDA to move potentially useful drugs to a patient market.… Read more »

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    A Proposed New FDA Drug Approval Pathway: “Conditional”

    With: Marty Tenenbaum, PhDAl Musella, DPM

    A Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY, and Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA Originally published April 5, 2017 Q: The delay time from discovery/observation, through validation to approval and distribution/use of new cancer treatments remains excessive. With promising experimental treatments, advanced computer technology and biostatistics, creative alternatives… Read more »

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    Practice-Changing Developments in Treatment of Metastatic NSCLC

    Emma Shtivelman, PhD

    Immune checkpoint inhibitor drugs that target the proteins PD-1 and PD-L1 are by now well established in the treatment of non-small cell lung cancer (NSCLC). In 2015, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo), an anti-PD-1 drug, for treatment of patients with metastatic NSCLC who progressed or relapsed after platinum-based chemotherapy. Atezolizumab (Tecentriq), an anti-PD-L1 drug, was approved in 2016 for… Read more »

  •   Emma Shtivelman, PhD

    Excerpt:

    “The Food and Drug Administration wants to help patients get faster access to promising cancer treatments.

    “The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House lawmakers on Thursday.

    “Drugmakers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.”

    Go to full article published by Bloomberg on Nov 30, 2017.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

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    War of the Checkpoint Inhibitors: Anti-PD-1 Drugs Move into First-Line Treatment in NSCLC

    Emma Shtivelman, PhD

    Last year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their… Read more »

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    New Treatments for Gastrointestinal Neuroendocrine Tumors

    Emma Shtivelman, PhD

    Neuroendocrine tumors (NETs) of the digestive system (GI-NETs) can arise in different parts of the digestive tract…Two new treatments for GI-NETs recently received much attention at the 2016 Gastrointestinal Cancers Symposium held in San Francisco in January. Researchers at the symposium presented clinical trial results that demonstrated the benefits of these new drugs.

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    The Growing Arsenal of Immunotherapy Drugs for Melanoma

    Emma Shtivelman, PhD

    Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic’ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type.

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    The Role of Pertuzumab in Treating HER2+ Breast Cancer

    Emma Shtivelman, PhD

    Pertuzumab (Perjeta) is a relatively new drug that targets HER2, a protein found at higher-than-normal levels in about 15% to 20% of all breast cancers. Too much HER2 leads to tumor growth. Currently, all newly diagnosed breast cancer patients have their tumors’ HER2 levels tested. Knowing whether a patient’s HER2 levels are abnormally high (HER2-positive) or normal (HER2-negative) is a major factor in choosing a treatment, thanks to the availability of trastuzumab (Herceptin) and, now, other HER2-targeted drugs such as Perjeta, T-DM1 (Kadcyla), and lapatinib (Tykerb). These drugs are all used to treat HER2-positive patients.